BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 9925369 · Received April 3, 2020

    Report

    Report Number
    3006630150-2020-01643
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    March 6, 2020
    Report Date
    August 20, 2020
    Manufacturer
    VERTIFLEX INC.
    Product Code
    NQO
    UDI-DI
    00884662000543
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF SPACER LOT NUMBER 800232 DID NOT CONFIRMED THE REPORTED COMPLAINT OF FAILURE TO OPEN, HOWEVER, VISUAL EXAMINATION REVEALED SIGNIFICANT DAMAGE. THE RIGHT WING OF THE SUPERIOR CAM-LOBE WAS SIGNIFICANTLY BENT TOWARDS THE MEDIAN LINE. ALTHOUGH THE CAM-LOBE WAS BENT, THE SPACER FUNCTIONED ACCEPTABLY UPON FUNCTIONAL TESTING. THE DAMAGE TO THE SPACER INDICATES THE FAILURE WAS LIKELY DUE TO FORCED DEPLOYMENT AGAINST A RIGID OBSTRUCTION (SPINOUS PROCESS). ANALYSIS OF SPACER LOT NUMBER 800236 REVEALED NO DEFECTS AS THE IMPLANT WAS COMPLETELY INTACT AND FUNCTIONED ACCEPTABLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE FIRST SPACER NOT DEPLOYING PROPERLY AND THE SECOND SPACER NOT SEATING PROPERLY. THE PHYSICIAN WAS NOT COMFORTABLE IMPLANTING THE PATIENT AFTER THE MULTIPLE ATTEMPTS SO THE PROCEDURE WAS ABORTED. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # 101-9814, LOT # 800236, DESCRIPTION: SUPERION IDS 14MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE FIRST SPACER NOT DEPLOYING PROPERLY AND THE SECOND SPACER NOT SEATING PROPERLY. THE PHYSICIAN WAS NOT COMFORTABLE IMPLANTING THE PATIENT AFTER THE MULTIPLE ATTEMPTS SO THE PROCEDURE WAS ABORTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387838 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO VERTIFLEX INC. 101-9812 800232 00884662000543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other